BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 22078242 · Received May 23, 2025

    Report

    Report Number
    3005180920-2025-00476
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030884993
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-05-2025: LOT 2404594: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-06-2024. EXPIRATION DATE: 2029-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 06-05-2025: M-VIZION 01.22.403 PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES (K201471) LOT 2010776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-09-2021. EXPIRATION DATE: 2026-09-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MECTACER 01.29.210 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L (K112115 LOT 2500710: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-02-2025. EXPIRATION DATE: 2030-01-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2430954: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-01-2025. EXPIRATION DATE: 2030-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. IMPACT 3D METAL 01.38.354MH MPACT 3D METAL SHELL MULTI HOLE THIN Ø54MM (K202568) LOT 2417813: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-09-2024. EXPIRATION DATE: 2029-08-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT TWO WEEKS, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818508 M-VIZION FEMORAL REVISION SYSTEM M-VIZION DISTAL STEM Ø13MM L 140MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.102 2404594 07630030884993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention